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    Clinical Trial Results:
    Effect of liraglutide on body weight and microvascular function in non-diabetic overweight women with coronary microvascular dysfunction

    Summary
    EudraCT number
    		 2015-002153-35
    Trial protocol
    		 DK  
    Global end of trial date
    18 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2021
    First version publication date
    13 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GAP
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bispebjerg Universitetshospital
    Sponsor organisation address
    Bispebjerg Bakke 23, København NV, Denmark, 2400
    Public contact
    Eva Prescott, Bispebjerg University Hospital, 0045 22572614, eva.irene.bossano.prescott@regionh.dk
    Scientific contact
    Eva Prescott, Bispebjerg University Hospital, 0045 22572614, eva.irene.bossano.prescott@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of treatment with Liraglutide on the coronary microvasculature and angina symptoms in overweight patients with microvascular dysfunction and angina pectoris but no coronary artery stenosis
    Protection of trial subjects
    Side-effects were evaluated regularly at up-titration visits by interview and blood samples, and study participants had access to a medical doctor at all times in case of any discomfort or doubts.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    12
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We included 33 women between November 19th 2015 and December 13th 2016 and 29 completed the study. We recruited women with angina like symptoms and no obstructive CAD defined as <50% coronary artery stenosis assessed by invasive CAG in eastern Denmark.

    Pre-assignment
    Screening details
    		 Participants from the iPOWER (ImProve diagnOsis and treatment of Women with angina pEctoris and micRovessel disease) study cohort. Of 938, 52 fullfilled inclusion criteria. 19 were excluded after baseline/screening visit and 33 were included.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 control
    Arm description
    		 No treatment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 intervention
    Arm description
    		 Liraglutide 3 mg daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    liraglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    3 mg administered subcutaineously once daily

    Number of subjects in period 1
    		control intervention
    Started
    33
    30
    Completed
    30
    29
    Not completed
    3
    1
         Adverse event, non-fatal
    -
    1
         unrelated to the study
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 33 33
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 12 12
        From 65-84 years
    		 21 21
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 33 33
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    control
    Reporting group description
    		 No treatment

    Reporting group title
    intervention
    Reporting group description
    		 Liraglutide 3 mg daily for 12 weeks

    Primary: Change in CFVR

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    End point title
    		 Change in CFVR
    End point description
    End point type
    Primary
    End point timeframe
    Change after 5 weeks in the control period and 12 weeks in the experimental period
    End point values
    		 control intervention
    Number of subjects analysed
    33
    29
    Units: ratio
        arithmetic mean (confidence interval 95%)
    0.11 (-0.02 to 0.25)
    0.07 (-0.07 to 0.21)
    Statistical analysis title
    		 mixed model
    Comparison groups
    intervention v control
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Seattle angina questionnaire 1

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    End point title
    		 Seattle angina questionnaire 1
    End point description
    Physical limitation score
    End point type
    Primary
    End point timeframe
    Control period of approximately 5 weeks and experimental period of approximately 12 weeks
    End point values
    		 control intervention
    Number of subjects analysed
    33
    29
    Units: score
        arithmetic mean (confidence interval 95%)
    -2.26 (-6.34 to 1.83)
    7.78 (3.41 to 12.12)
    Statistical analysis title
    		 mixed model
    Comparison groups
    control v intervention
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Seattle Angina Questionnaire 2

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    End point title
    		 Seattle Angina Questionnaire 2
    End point description
    Angina stability score
    End point type
    Primary
    End point timeframe
    Change in the control period after approximately 5 weeks and after the experimental period of approximately 12 weeks
    End point values
    		 control intervention
    Number of subjects analysed
    33
    29
    Units: score
        arithmetic mean (confidence interval 95%)
    -9.29 (-20.61 to 2.03)
    26.60 (14.85 to 38.35)
    Statistical analysis title
    		 mixed model
    Comparison groups
    control v intervention
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Seattle Angina Questionnaire 3

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    End point title
    		 Seattle Angina Questionnaire 3
    End point description
    Angina frequency score
    End point type
    Primary
    End point timeframe
    control period of 5 weeks and experimental period of 12 weeks
    End point values
    		 control intervention
    Number of subjects analysed
    33
    29
    Units: score
        arithmetic mean (confidence interval 95%)
    -1.38 (-6.10 to 3.33)
    8.48 (3.52 to 13.44)
    Statistical analysis title
    		 mixed model
    Comparison groups
    control v intervention
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Seattle Angina Questionnaire 4

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    End point title
    		 Seattle Angina Questionnaire 4
    End point description
    Treatment satisfaction score
    End point type
    Primary
    End point timeframe
    control period of 5 weeks and experimental period of 12 weeks
    End point values
    		 control intervention
    Number of subjects analysed
    33
    29
    Units: score
        arithmetic mean (confidence interval 95%)
    2.68 (-5.12 to 10.47)
    9.18 (1.08 to 17.28)
    Statistical analysis title
    		 mixed model
    Comparison groups
    control v intervention
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Primary: Seattle Angina Questionnaire 5

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    End point title
    		 Seattle Angina Questionnaire 5
    End point description
    Disease perception score
    End point type
    Primary
    End point timeframe
    control period of 5 weeks and experimental period of 12 weeks
    End point values
    		 control intervention
    Number of subjects analysed
    33
    29
    Units: score
        arithmetic mean (confidence interval 95%)
    8.11 (3.16 to 13.06)
    1.82 (-3.33 to 6.97)
    Statistical analysis title
    		 mixed model
    Comparison groups
    control v intervention
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Changes in endothelial function assessed by flow mediated dilation (FMD) of the brachial artery by ultrasound

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    End point title
    		 Changes in endothelial function assessed by flow mediated dilation (FMD) of the brachial artery by ultrasound
    End point description
    End point type
    Secondary
    End point timeframe
    Intervention period compared with control period
    End point values
    		 control intervention
    Number of subjects analysed
    33
    29
    Units: ratio
        arithmetic mean (confidence interval 95%)
    0.60 (-2.09 to 3.28)
    0.48 (-2.39 to 3.35)
    Statistical analysis title
    		 mixed model
    Comparison groups
    intervention v control
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Median difference (final values)
    Confidence interval

    Secondary: Changes in cardiac function assessed by speckle tracking echocardiography

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    End point title
    		 Changes in cardiac function assessed by speckle tracking echocardiography
    End point description
    End point type
    Secondary
    End point timeframe
    control period of 5 weeks and experimental period of 12 weeks
    End point values
    		 control intervention
    Number of subjects analysed
    33
    29
    Units: percent
        arithmetic mean (confidence interval 95%)
    -0.45 (-1.18 to 0.28)
    0.14 (-0.61 to 0.90)
    Statistical analysis title
    		 mixed model
    Comparison groups
    control v intervention
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Secondary: Change in body weight

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    End point title
    		 Change in body weight
    End point description
    End point type
    Secondary
    End point timeframe
    control period of 5 weeks and experimental period of 12 weeks
    End point values
    		 control intervention
    Number of subjects analysed
    33
    29
    Units: kilogram(s)
        arithmetic mean (confidence interval 95%)
    0.55 (-0.23 to 1.32)
    -6.03 (-6.84 to -5.22)
    Statistical analysis title
    		 mixed model
    Comparison groups
    control v intervention
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    adverse event were reported during the inverventional period from day one on liraglutide until one week after last dosage.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 30 (100.00%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    11 / 30 (36.67%)
         occurrences all number
    11
    Discomfort
         subjects affected / exposed
    4 / 30 (13.33%)
         occurrences all number
    4
    Injection related reaction
         subjects affected / exposed
    1 / 30 (3.33%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    18 / 30 (60.00%)
         occurrences all number
    18
    Gastrointestinal disorders
    Appetite disorder
         subjects affected / exposed
    29 / 30 (96.67%)
         occurrences all number
    29
    Vomiting
         subjects affected / exposed
    6 / 30 (20.00%)
         occurrences all number
    6
    Gastrointestinal pain
         subjects affected / exposed
    27 / 30 (90.00%)
         occurrences all number
    27

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30773266
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